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Cotton fiber-based assay with time-based microfluidic absorption sampling for point-of-care applications

Wicaksono DH, Syazwani IN, Ratnarathorn N, Sadir S, Shahir S, Ruckthong L, et al.

Bioanalysis, 2019 May;11(9):855-873.
PMID: 31084195 DOI: 10.4155/bio-2018-0190

Aim: Time-based microfluidic absorption sampling was proposed using cotton fiber-based device made in swab stick. The assay was optimized and compared with conventional pipetted drop sampling using the same device. Materials & methods: Reagents were integrated into cotton fiber device for assessing concentration of analytes by the colorimetric detection method through time-based absorption sampling microfluidic system. All assay parameters were first optimized using conventional pipette-based drop sampling. Results: The color intensity is linear in the relevant concentration range of the analytes. The LOD are 0.189 mM for glucose and 6.56 μM for nitrite, respectively. These values are better than conventional drop sampling. The fiber-containing swab itself functions as sampling, assay and calibration device. Conclusion: Microfluidic cotton fiber-based assay device was fabricated and can determine analyte concentration in artificial salivary samples, colorimetrically, by time-based absorption sampling without the need of complex equipments.

Matched MeSH terms: Point-of-Care Systems*
Fulltext Haemoglobin A1c: comparing performance of two point of care devices with laboratory analyser

Wan Mohd Zin RM, Ahmad Kamil ZI, Tuan Soh TR, Embong M, Wan Mohamud WN

BMC Res Notes, 2013 Dec 18;6:540.
PMID: 24344903 DOI: 10.1186/1756-0500-6-540

BACKGROUND: Measurement of HbA1c has been widely used for long-term monitoring and management of diabetes control. There is increasing use of point-of-care (POC) devices for measuring HbA1c where quicker results would allow immediate clinical management decisions to be made. Therefore, it is important to evaluate and compare the performance of such devices to the reference laboratory method.
FINDINGS: A total of 274 venous blood was collected from normal healthy adults during the community screening programmes. The performance of POC devices, Afinion and Quo-test were compared to central laboratory HPLC method; Adams A1c HA 8160. Both POC devices showed good correlation to HA 8160 with r = 0.94 (p < 0.001) and r = 0.95 (p < 0.001) for Afinion and Quo-test respectively. The means difference were statistically higher between POC and HA 8160 with 0.23% (95% CI 0.19-0.26, p < 0.001) and 0.29% (95% CI 0.24-0.34, p < 0.001) for Afinion and Quo-test respectively.
CONCLUSIONS: Both POC devices could be considered in health clinics for diabetes management but not to be used for the diagnostic purposes.

Matched MeSH terms: Point-of-Care Systems/standards*
Fulltext A comparison between the effectiveness of a gamified approach with the conventional approach in point-of-care ultrasonographic training

Lai AKH, Noor Azhar AMB, Bustam AB, Tiong XT, Chan HC, Ahmad RB, et al.

BMC Med Educ, 2020 Aug 12;20(1):263.
PMID: 32787921 DOI: 10.1186/s12909-020-02173-7

BACKGROUND: Although gamification increases user engagement, its effectiveness in point-of-care ultrasonographic training has yet to be fully established. This study was conducted with the primary outcome of evaluating its effectiveness in point-of-care ultrasonographic training as compared to conventional approach.
METHODS: Participants consisting of junior doctors were randomized into either the (1) gamified or the (2) conventional educational approach for ultrasonographic training.
RESULTS: A total of 31 junior doctors participated in this study (16 participants in gamified arm, 15 in the conventional arm after one participant from the conventional arm dropped out due to work commitment). Two-way mixed ANOVA test showed that there was no statistically significant interaction between the types of educational approach and time of testing (pre-test, post-test, 2 months post-training) for both theoretical knowledge score and practical skills score, with F(2, 58) = 39.6, p point-of-care ultrasonographic training.

Matched MeSH terms: Point-of-Care Systems*
Fulltext Pulmonary tuberculosis in outpatients in Sabah, Malaysia: advanced disease but low incidence of HIV co-infection

William T, Parameswaran U, Lee WK, Yeo TW, Anstey NM, Ralph AP

BMC Infect Dis, 2015;15:32.
PMID: 25636334 DOI: 10.1186/s12879-015-0758-6

BACKGROUND: Tuberculosis (TB) is generally well controlled in Malaysia, but remains an important problem in the nation's eastern states. In order to better understand factors contributing to high TB rates in the eastern state of Sabah, our aims were to describe characteristics of patients with TB at a large outpatient clinic, and determine the prevalence of HIV co-infection. Additionally, we sought to test sensitivity and specificity of the locally-available point-of-care HIV test kits.
METHODS: We enrolled consenting adults with smear-positive pulmonary TB for a 2-year period at Luyang Clinic, Kota Kinabalu, Malaysia. Participants were questioned about ethnicity, smoking, prior TB, disease duration, symptoms and comorbidities. Chest radiographs were scored using a previously devised tool. HIV was tested after counselling using 2 point-of-care tests for each patient: the test routinely in use at the TB clinic (either Advanced Quality™ Rapid Anti-HIV 1&2, FACTS anti-HIV 1/2 RAPID or HIV (1 + 2) Antibody Colloidal Gold), and a comparator test (Abbott Determine™ HIV-1/2, Inverness Medical). Positive tests were confirmed by enzyme immunoassay (EIA), particle agglutination and line immunoassay.
RESULTS: 176 participants were enrolled; 59 (33.5%) were non-Malaysians and 104 (59.1%) were male. Smoking rates were high (81/104 males, 77.9%), most had cavitary disease (51/145, 64.8%), and 81/176 (46.0%) had haemoptysis. The median period of symptoms prior to treatment onset was 8 weeks. Diabetes was present in 12. People with diabetes or other comorbidities had less severe TB, suggesting different healthcare seeking behaviours in this group. All participants consented to HIV testing: three (1.7%) were positive according to Determine™ and EIA, but one of these tested negative on the point-of-care test available at the clinic (Advanced Quality™ Rapid Anti-HIV 1&2). The low number of positive tests and changes in locally-available test type meant that accurate estimates of sensitivity and specificity were not possible.
CONCLUSION: Patients had advanced disease at diagnosis, long diagnostic delays, low HIV co-infection rates, high smoking rates among males, and migrants may be over-represented. These findings provide important insights to guide local TB control efforts. Caution is required in using some point-of-care HIV tests, and ongoing quality control measures are of major importance.
Study site: Klinik Kesihatan Luyang (Tuberculosis Clinic), Kota Kinabalu, Sabah, Malaysia,

Matched MeSH terms: Point-of-Care Systems
Fulltext Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia

Chong ZL, Sekaran SD, Soe HJ, Peramalah D, Rampal S, Ng CW

BMC Infect Dis, 2020 Mar 12;20(1):210.
PMID: 32164538 DOI: 10.1186/s12879-020-4911-5

BACKGROUND: Dengue is an emerging infectious disease that infects up to 390 million people yearly. The growing demand of dengue diagnostics especially in low-resource settings gave rise to many rapid diagnostic tests (RDT). This study evaluated the accuracy and utility of ViroTrack Dengue Acute - a new biosensors-based dengue NS1 RDT, SD Bioline Dengue Duo NS1/IgM/IgG combo - a commercially available RDT, and SD Dengue NS1 Ag enzyme-linked immunosorbent assay (ELISA), for the diagnosis of acute dengue infection.
METHODS: This prospective cross-sectional study consecutively recruited 494 patients with suspected dengue from a health clinic in Malaysia. Both RDTs were performed onsite. The evaluated ELISA and reference tests were performed in a virology laboratory. The reference tests comprised of a reverse transcription-polymerase chain reaction and three ELISAs for the detection of dengue NS1 antigen, IgM and IgG antibodies, respectively. The diagnostic performance of evaluated tests was computed using STATA version 12.
RESULTS: The sensitivity and specificity of ViroTrack were 62.3% (95%CI 55.6-68.7) and 95.0% (95%CI 91.7-97.3), versus 66.5% (95%CI 60.0-72.6) and 95.4% (95%CI 92.1-97.6) for SD NS1 ELISA, and 52.4% (95%CI 45.7-59.1) and 97.7% (95%CI 95.1-99.2) for NS1 component of SD Bioline, respectively. The combination of the latter with its IgM and IgG components were able to increase test sensitivity to 82.4% (95%CI 76.8-87.1) with corresponding decrease in specificity to 87.4% (95%CI 82.8-91.2). Although a positive test on any of the NS1 assays would increase the probability of dengue to above 90% in a patient, a negative result would only reduce this probability to 23.0-29.3%. In contrast, this probability of false negative diagnosis would be further reduced to 14.7% (95%CI 11.4-18.6) if SD Bioline NS1/IgM/IgG combo was negative.
CONCLUSIONS: The performance of ViroTrack Dengue Acute was comparable to SD Dengue NS1 Ag ELISA. Addition of serology components to SD Bioline Dengue Duo significantly improved its sensitivity and reduced its false negative rate such that it missed the fewest dengue patients, making it a better point-of-care diagnostic tool. New RDT like ViroTrack Dengue Acute may be a potential alternative to existing RDT if its combination with serology components is proven better in future studies.

Matched MeSH terms: Point-of-Care Systems
In-Transit Electroextraction of Small-Molecule Pharmaceuticals from Blood

Nanthasurasak P, See HH, Zhang M, Guijt RM, Breadmore MC

Angew Chem Int Ed Engl, 2019 03 18;58(12):3790-3794.
PMID: 30614157 DOI: 10.1002/anie.201812077

An electrokinetic platform was developed for extracting small-molecule pharmaceuticals from a dried blood spot. Through the exclusion of liquid reagents and use of low field strength (6 V cm-1 ), the electroextraction of a drug from a dried blood spot, deposited on a polymer inclusion membrane (PIM), could be realised while in transit in the mail. In transit sample preparation provides a potential solution to in situ sample degradation and may accelerate the workflow upon arrival of a patient sample at the analytical facility. The electroextraction method was enabled through our discovery of the use of 15-20 μm thin PIMs as electrophoretic separation medium in absence of liquid reagents. Here, a PIM consisting of cellulose triacetate as polymer base, 2-nitrophenyl octyl ether as plasticizer and 1-ethyl-3-methylimidazolium bis(trifluoromethylsulfonyl)imide as carrier was used. The PIM, was packaged with two 12 V batteries to supply the separation voltage. A blood spot containing berberine chloride was deposited and dried before the applying the separation potential, allowing for the electroextraction while the packaged device was shipped in internal mail. Upon arrival in the analytical laboratory, the PIM was analysed using a fluorescence microscope with photon multiplier tube, quantifying the berberine extracted away from the sample matrix. This platform represents a new opportunity for processing clinical samples during transport to the laboratory, saving time and manual handling to accelerate the time to result.

Matched MeSH terms: Point-of-Care Systems
Polydimethylsiloxane-Paper Hybrid Lateral Flow Assay for Highly Sensitive Point-of-Care Nucleic Acid Testing

Choi JR, Liu Z, Hu J, Tang R, Gong Y, Feng S, et al.

Anal Chem, 2016 06 21;88(12):6254-64.
PMID: 27012657 DOI: 10.1021/acs.analchem.6b00195

In nucleic acid testing (NAT), gold nanoparticle (AuNP)-based lateral flow assays (LFAs) have received significant attention due to their cost-effectiveness, rapidity, and the ability to produce a simple colorimetric readout. However, the poor sensitivity of AuNP-based LFAs limits its widespread applications. Even though various efforts have been made to improve the assay sensitivity, most methods are inappropriate for integration into LFA for sample-to-answer NAT at the point-of-care (POC), usually due to the complicated fabrication processes or incompatible chemicals used. To address this, we propose a novel strategy of integrating a simple fluidic control strategy into LFA. The strategy involves incorporating a piece of paper-based shunt and a polydimethylsiloxane (PDMS) barrier to the strip to achieve optimum fluidic delays for LFA signal enhancement, resulting in 10-fold signal enhancement over unmodified LFA. The phenomena of fluidic delay were also evaluated by mathematical simulation, through which we found the movement of fluid throughout the shunt and the tortuosity effects in the presence of PDMS barrier, which significantly affect the detection sensitivity. To demonstrate the potential of integrating this strategy into a LFA with sample-in-answer-out capability, we further applied this strategy into our prototype sample-to-answer LFA to sensitively detect the Hepatitis B virus (HBV) in clinical blood samples. The proposed strategy offers great potential for highly sensitive detection of various targets for wide application in the near future.

Matched MeSH terms: Point-of-Care Systems*
Fulltext Point-of-Care for Evaluating Antimicrobial Resistance through the Adoption of Functional Materials

Singh S, Numan A, Cinti S

Anal Chem, 2022 Jan 11;94(1):26-40.
PMID: 34802244 DOI: 10.1021/acs.analchem.1c03856
Matched MeSH terms: Point-of-Care Systems
Development of multiplex loop mediated isothermal amplification (m-LAMP) label-based gold nanoparticles lateral flow dipstick biosensor for detection of pathogenic Leptospira

Nurul Najian AB, Engku Nur Syafirah EA, Ismail N, Mohamed M, Yean CY

Anal Chim Acta, 2016 Jan 15;903:142-8.
PMID: 26709307 DOI: 10.1016/j.aca.2015.11.015

In recent years extensive numbers of molecular diagnostic methods have been developed to meet the need of point-of-care devices. Efforts have been made towards producing rapid, simple and inexpensive DNA tests, especially in the diagnostics field. We report on the development of a label-based lateral flow dipstick for the rapid and simple detection of multiplex loop-mediated isothermal amplification (m-LAMP) amplicons. A label-based m-LAMP lateral flow dipstick assay was developed for the simultaneous detection of target DNA template and a LAMP internal control. This biosensor operates through a label based system, in which probe-hybridization and the additional incubation step are eliminated. We demonstrated this m-LAMP assay by detecting pathogenic Leptospira, which causes the re-emerging disease Leptospirosis. The lateral flow dipstick was developed to detect of three targets, the LAMP target amplicon, the LAMP internal control amplicon and a chromatography control. Three lines appeared on the dipstick, indicating positive results for all representative pathogenic Leptospira species, whereas two lines appeared, indicating negative results, for other bacterial species. The specificity of this biosensor assay was 100% when it was tested with 13 representative pathogenic Leptospira species, 2 intermediate Leptospira species, 1 non-pathogenic Leptospira species and 28 other bacteria species. This study found that this DNA biosensor was able to detect DNA at concentrations as low as 3.95 × 10(-1) genomic equivalent ml(-1). An integrated m-LAMP and label-based lateral flow dipstick was successfully developed, promising simple and rapid visual detection in clinical diagnostics and serving as a point-of-care device.

Matched MeSH terms: Point-of-Care Systems
Fulltext Efficacy and safety of the point-of-care procalcitonin test for determining the antibiotic treatment duration in patients with ventilator-associated pneumonia in the intensive care unit: a randomised controlled trial

Z Mazlan M, A H Ismail M, Ali S, Salmuna ZN, Wan Muhd Shukeri WF, Omar M

Anaesthesiol Intensive Ther, 2021;53(3):207-214.
PMID: 34006044 DOI: 10.5114/ait.2021.104300

INTRODUCTION: This study was conducted to assess the efficacy of point-of-care (POC) procalcitonin (PCT) serial measurement in determining the antibiotic treatment duration in patients with ventilator-associated pneumonia (VAP).
MATERIAL AND METHODS: One hundred patients were randomly recruited and then further randomly divided into two groups of 50 patients each. The first group used the POC PCT test along with the standard sepsis parameter monitoring, while the second group had the standard monitoring only (C-reactive protein [CRP] level, total white count, temperature and tracheal aspirate culture). Serial PCT test results and CRP levels were monitored on days 1, 3, 7 and 9. The patients were followed up for 28-day mortality.
RESULTS: Eighty-five patients completed the trial, of whom 43 were in the PCT group and 42 were in the control group. The PCT group had a significantly lower mean (SD) antibiotic treatment duration (10.28 [2.68] days) than the control group (11.52 [3.06]). The mean (SD) difference was -1.25 (95% confidence interval [CI], -2.48 to 0.01; t-statistic [df] = -1.997 [83]; P = 0.049). The PCT group also had a higher number of antibiotic-free days alive during the 28 days after VAP onset than the control group (mean [SD], 10.79 [7.61] vs. 8.72 [6.41]). The Sequential Organ Failure Assessment score was the sole factor for the decrease in duration after VAP onset (regression coefficient β [95% CI], -0.70 [-1.19 to -0.20]; P = 0.006).
CONCLUSIONS: The POC procalcitonin test can reduce the antibiotic treatment duration in patients with VAP.

Matched MeSH terms: Point-of-Care Systems
Lateral Flow Assay Based on Paper-Hydrogel Hybrid Material for Sensitive Point-of-Care Detection of Dengue Virus

Choi JR, Yong KW, Tang R, Gong Y, Wen T, Yang H, et al.

Adv Healthc Mater, 2017 Jan;6(1).
PMID: 27860384 DOI: 10.1002/adhm.201600920

Paper-based devices have been broadly used for the point-of-care detection of dengue viral nucleic acids due to their simplicity, cost-effectiveness, and readily observable colorimetric readout. However, their moderate sensitivity and functionality have limited their applications. Despite the above-mentioned advantages, paper substrates are lacking in their ability to control fluid flow, in contrast to the flow control enabled by polymer substrates (e.g., agarose) with readily tunable pore size and porosity. Herein, taking the benefits from both materials, the authors propose a strategy to create a hybrid substrate by incorporating agarose into the test strip to achieve flow control for optimal biomolecule interactions. As compared to the unmodified test strip, this strategy allows sensitive detection of targets with an approximately tenfold signal improvement. Additionally, the authors showcase the potential of functionality improvement by creating multiple test zones for semi-quantification of targets, suggesting that the number of visible test zones is directly proportional to the target concentration. The authors further demonstrate the potential of their proposed strategy for clinical assessment by applying it to their prototype sample-to-result test strip to sensitively and semi-quantitatively detect dengue viral RNA from the clinical blood samples. This proposed strategy holds significant promise for detecting various targets for diverse future applications.

Matched MeSH terms: Point-of-Care Systems*
A point-of-care cassette test for detection of Strongyloides stercoralis

Noordin R, Osman E, Kalantari N, Anuar NS, Gorgani-Firouzjaee T, Sithithaworn P, et al.

Acta Trop, 2022 Feb;226:106251.
PMID: 34808116 DOI: 10.1016/j.actatropica.2021.106251

Strongyloides stercoralis is a parasite that causes strongyloidiasis worldwide. It may lead to a life-long infection in immunocompetent people and hyperinfection in immunosuppressed patients. A point-of-care (POC) rapid test is helpful for patient diagnosis in resource-limited settings and as a detection tool in elimination/control programs. Previously, we reported a rapid IgG4 dipstick test (Ss Rapid®) for Strongyloides suitable for a laboratory setting. A POC cassette format of the test, which is field-applicable, has since been developed. Here, we report on a laboratory-based evaluation of the Ss Rapid® cas sette test on 285 sera. We assessed the diagnostic sensitivity of the Ss Rapid® cas sette with 32 sera, comprising samples from larval and/or DNA positive individuals from three countries. Additionally, we also tested samples from 33 seropositive endemic areas residents. We evaluated the diagnostic specificity of the test using 220 samples, comprising sera from other infections (n = 101), allergy cases with high IgE antibodies (n = 4), and blood donors (n = 115). The test showed high diagnostic sensitivity (97%, 31/32), and all sera of the seropositive endemic residents were reactive. It also showed high diagnostic specificity (94.5%, 208/220), and all false-positive samples tested negative after sera adsorption using recombinant NIE-coated microsphere beads. Additionally, we showed that the test worked with spiked whole blood samples. The study results showed that the SsRapid® cas sette test merits further laboratory and field evaluations.

Matched MeSH terms: Point-of-Care Systems

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